Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout

Summary

The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the concomitant use of pegloticase with MTX, by comparing pegloticase co-administered with MTX to pegloticase co-administered with placebo for MTX in adults with uncontrolled gout.

Conditions

• Gout

Interventions

BIOLOGICAL

Pegloticase

IV pegloticase 8 mg Q2W

DRUG

methotrexate

Oral MTX 15 mg weekly

DRUG

placebo

Oral placebo for MTX

DIETARY_SUPPLEMENT

folic acid

Folic acid 1 mg orally every day beginning at Week -6 until prior to the Week 52 Visit.

DRUG

gout flare prophylaxis regimen

Prior to beginning the Pegloticase + IMM Period, participants must have been taking at least 1 protocol-standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤ 10 mg/day) for ≥ 1 week before the first dose of pegloticase and to continue flare prophylaxis per American College of Rheumatology guidelines \[Khanna D et al. 2012\] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA \< 6 mg/dL) for participants with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA \< 5 mg/dL) for participants with one or more tophi detected on initial physical exam that then resolved.

DRUG

fexofenadine

For IR prophylaxis, fexofenadine (180 mg orally) taken the day before each infusion and on the morning of each infusion.

DRUG

acetaminophen

For IR prophylaxis, acetaminophen (1000 mg orally) taken the morning of each infusion.

DRUG

methylprednisolone

For IR prophylaxis, methylprednisolone (125 mg IV) given over an infusion duration between 10 - 30 minutes, immediately prior to each infusion.

Sponsors & Collaborators

• Amgen

  lead INDUSTRY

Principal Investigators

• MD · Amgen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-13

Primary Completion

2021-03-17

Completion

2022-04-11

FDA Drug

Yes

Countries

• United States

Study Locations